Protens Electrode
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identity
- Trade Name
- PROTENS EUDAMED
- Device Name
- TENS Electrode EUDAMED
- Model / Reference
- 4848LE EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08809083947910 EUDAMED
- Basic UDI-DI
- 880908394050KQ EUDAMED
- 510(k) Number
- K042301 FDA 510(k)
- FDA Product Code
- GXY FDA 510(k)
- EMDN Code
- N010201 TENS SYSTEM ELECTRODES EUDAMED
Classification
- Device Class
- Class I EUDAMEDClass II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 882.1320 FDA 510(k)
- Regulation Number
- 882.1320 FDA 510(k)
- Market of Registration
- Spain EUDAMED
- Advisory Committee
- Neurology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
Clinical & Handling
Sterile
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
The Protens Electrode RG02WCBZGN (NS) is a disposable conductive electrode designed for transcutaneous electrical nerve stimulation (TENS) applications. It serves as the conductive interface between a TENS generator and the patient’s skin, facilitating the delivery of electrical impulses for therapeutic purposes. These electrodes are categorized under electrical stimulation devices and are intended for use with existing TENS systems to modulate pain or muscle function. Their design ensures reliable signal transmission while maintaining patient comfort and safety during treatment.
The Protens Electrode RG02WCBZGN (NS) is supplied as a single-use, non-sterile device, intended for outpatient or home use in clinical or rehabilitative settings. It adheres to FDA 510(k) clearance (K042301, GXY) and MDR compliance, ensuring adherence to regulatory standards for electrical medical devices. The electrode is packaged individually for hygiene and ease of use, with no specified MRI compatibility. Storage should follow manufacturer guidelines to preserve conductivity and integrity until use.
Frequently asked questions
What is the Protens Electrode RG02WCBZGN (NS) primarily used for in clinical settings?
The Protens Electrode RG02WCBZGN (NS) is designed specifically for transcutaneous electrical nerve stimulation (TENS) applications. It acts as the conductive interface between a TENS generator and the patient’s skin, enabling the delivery of electrical impulses to modulate pain or assist in muscle function during therapeutic or rehabilitative treatments. It is intended for outpatient or home use in clinical settings.
Is the Protens Electrode RG02WCBZGN (NS) reusable, and if not, how is it supplied?
No, the Protens Electrode RG02WCBZGN (NS) is a single-use device. It is packaged individually to ensure hygiene and ease of use, which is particularly important for maintaining patient safety and preventing cross-contamination in clinical or home settings.
What regulatory pathways does the Protens Electrode RG02WCBZGN (NS) follow, and what does this mean for its use?
The Protens Electrode RG02WCBZGN (NS) follows both FDA 510(k) clearance (K042301, product code GXY) and MDR compliance. The FDA 510(k) clearance indicates it has been deemed substantially equivalent to a legally marketed device, ensuring it meets regulatory standards for electrical stimulation devices. This means it can be legally marketed and used in the U.S. for its intended purpose as described in the device’s labeling.
How should the Protens Electrode RG02WCBZGN (NS) be stored to maintain its functionality?
The Protens Electrode RG02WCBZGN (NS) should be stored according to the manufacturer’s guidelines to preserve its conductivity and structural integrity. While specific storage conditions aren’t detailed here, adhering to these instructions ensures the electrode remains effective and safe for use when needed, particularly in maintaining its performance for reliable signal transmission during TENS therapy.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: PROTENS ELECTRODE by BIO PROTECH, INC. | FDA 510 (k) Summary, Bio Protech PROTENS TENS Electrode - RG02WCBZGN (NS), Bio-Protech | Medical Electrode & Surgical Device Manufacturer, Bio Protech Protens Cloth Carbon Electrode - Rehab Store
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K042301 | Class II | Active |
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Manufacturer
- Manufacturer
- Bio Protech Inc.
- FDA Applicant
- Bio Protech, Inc.
Sources (2)
- FDA 510(k) K042301 24 fields · synced Sep 20, 2026
- EUDAMED 5b773ed7-e9d2-4d0e-be1a-5055fa664c45 61 fields · synced Jul 21, 2026